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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043344
Receipt No. R000049490
Scientific Title The effect of channa striata on tuberculosis outcome in children
Date of disclosure of the study information 2021/04/10
Last modified on 2021/02/16

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Basic information
Public title Effect of channa striata on tuberculosis in children
Acronym effect of channa striatus on nutritional status and cytokine level in tuberculosis children
Scientific Title The effect of channa striata on tuberculosis outcome in children
Scientific Title:Acronym effect channa striata on body mass index, Leptin level, albumin level, TNF-s, IFN-gamma in tuberculosis children
Region
Asia(except Japan)

Condition
Condition clinical trial on supplementary drug for tuberculosis in children
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to analyze the effect of channa striata on tuberculosis in children
Basic objectives2 Others
Basic objectives -Others to analyze the differences of cytokine level (TNF-a, IFN-gamma, IGF-b), leptin level, albumin level, and body mass index before and after suplementation.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes outcome of tuberculosis in children after 2 month suplementation of channa striata
Key secondary outcomes improvement of albumin level
improvement of leptin level
improvement of cytokine level (TNF-a, IFN-gamma, IGF-beta)
improvement of body mass index

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 channa striata extract for 2 month
subject 2-5 years dose 2x250 mg
subject 6-14 years dose 2x500 mg
Interventions/Control_2 placebo with same form and eticket, with capsul or syrup glukosa base
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
2 years-old <=
Age-upper limit
14 years-old >=
Gender Male and Female
Key inclusion criteria clinical tuberculosis of lung in children 2-14 years old
Key exclusion criteria severe tuberculosis form, include extrapulmonary TB, MDR TB
severe malnutrition
severe chronic disease
acute infectious disease on enrollement or admission
HIV positif
Target sample size 70

Research contact person
Name of lead principal investigator
1st name MOH
Middle name SYAROFIL
Last name ANAM
Organization lecturer at diponegoro university faculty of medicine
Division name pediatric respirology
Zip code 50244
Address Bagian/KSM Ilmu Kesehatan Anak FK Undip/RSUP dr. Kariadi Semarang. Jl. dr Sutomo No.16. Gedung C1L2
TEL 081367428988
Email msanam77@fk.undip.ac.id

Public contact
Name of contact person
1st name MOH
Middle name SYAROFIL
Last name ANAM
Organization lecturer at diponegoro university faculty of medicine
Division name pediatric respirology
Zip code 50244
Address Bagian/KSM Ilmu Kesehatan Anak FK Undip/RSUP dr. Kariadi Semarang. Jl. dr Sutomo No.16. Gedung C1L2
TEL 0248414296
Homepage URL https://www.undip.ac.id
Email msanam77@fk.undip.ac.id

Sponsor
Institute faculty of medicine diponegoro university
Institute
Department

Funding Source
Organization faculty of medicine diponegoro university
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Indonesia

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Komisi Etik Penelitian Kesehatan FK Undip
Address Jl. Dr. Sutomo No.18 Semarang
Tel 02476928010 (p.7820)
Email komisietik@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions diponegoro university (semarang, indonesia)

Other administrative information
Date of disclosure of the study information
2021 Year 04 Month 10 Day

Related information
URL releasing protocol on going
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2019 Year 07 Month 01 Day
Date of IRB
2019 Year 08 Month 21 Day
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2021 Year 04 Month 01 Day
Date of closure to data entry
2021 Year 04 Month 10 Day
Date trial data considered complete
2021 Year 07 Month 01 Day
Date analysis concluded
2021 Year 08 Month 01 Day

Other
Other related information On going research

Management information
Registered date
2021 Year 02 Month 16 Day
Last modified on
2021 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049490

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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